October 14, 2011

A group of bipartisan Senators including Senators Amy Klobuchar (D-MN), Richard Burr (R-NC), and Michael Bennet (D-CO) introduced The “Medical Device Regulatory Improvement Act “to help boost medical innovation by reducing regulatory burdens that unnecessarily delay beneficial new medical products from reaching patients.” The legislation would help streamline the Food and Drug Administration’s (FDA) regulation of medical devices to continue to spur innovation and help get new, lifesaving products to the market quicker without compromising consumer safety.

More importantly, the legislation would restore the appropriate balance to conflicts of interest requirements by requiring the FDA to be subject to the same conflicts of interest requirements as the rest of the federal government, under the Federal Advisory Committee Act. The legislation would also direct the FDA to contract with an outside entity to conduct a thorough review of the management and regulatory processes at the FDA’s Center for Devices and Radiological Health, including the impact on medical device innovation.

Background

Approximately three years ago, the Food and Drug Administration (FDA) enacted strict standards and rules to manage potential conflicts of interest for its advisory committees. The current regulations prohibit participation on an FDA advisory committee who has potentially conflicting financial interests totaling more than $50,000.

FDA advisory committees play an essential role in FDA’s activities to protect and promote public health through the regulation of human and animal drugs, biological products, medical devices, foods, and tobacco products.

With forty-nine committees and more than 600 members, advisory committees advise FDA in their process to approve drugs and policies. These advisory committees provide independent expert advice and recommendations on scientific, technical, and policy matters related to FDA-regulated products. The FDA however, is not required to follow panel advice when deciding whether to approve new drugs but often does.

Advisory committees enhance FDA’s ability to protect and promote public health by ensuring FDA has access to such advice through the public hearing process as provided in existing laws and regulations.

However, as a result of the strict conflict of interest rules adopted by FDA three years ago, it was reported last year that 218 positions of the 600-plus on FDA's 49 advisory committees had yet to be filled, in part because the FDA tightened guidelines in 2007 to minimize industry ties that could pose a potential conflict of interest.

The study examined a total of 221 meetings held by 16 advisory committees. Of the committees studied, 7 of 16 were able to keep their conflict rates at or below 20%. Overall, the study reported that the meeting-level analysis did not show a statistically significant relationship between conflict rates (“index conflict,” “competitor conflict,” or “any conflict”) and voting patterns.

In other words, the researchers tested for a relationship not between conflict of interest and yes votes on a drug but between conflicts of interest and votes for the interest of a pharmaceutical company. Moreover, the research indicated that in all three conflict categories, the exclusion of advisory committee members and voting consultants with conflicts would have produced margins less favorable to the index drug in the majority of meetings, but this would not have changed whether the majority favored or opposed the drug.

From these findings, the researchers concluded that a weak relationship between certain types of conflicts and voting behaviors was detected, and that excluding advisory committee members and voting consultants with conflicts would not have altered the overall vote outcome at any meeting studied.

Changing FDA Conflict of Interest Rules

Earlier this summer, talks about changing the conflict of interest rules began to grow between FDA officials and Congress, particularly in light of numerous reports that the regulatory framework at FDA, particularly with respect to medical devices, was slowing innovation and progress.

For example, at a House Energy and Commerce Subcommittee on Health hearing this summer, Janet Woodcock, Director of the Centers for Drug Evaluation and Research (CDER), noted that, “the [conflict of interest] limits have slowed down the advisory committee process.” She further explained that the agency was having difficulty in recruiting highly qualified people for its advisory panels.

Shortly thereafter, FDA Commissioner Margaret Hamburg was also noted saying that the conflict of interest rules may soon be loosened. Hamburg emphasized the importance of FDA having “subject-matter experts … for [the agency’s] important decision making” process.

The Medical Device Regulatory Improvement Act (S. 1700)

In announcing the legislation, the Senators correctly recognized that current conflicts of interest restrictions are overly stringent, giving the FDA difficulty finding qualified experts to serve on advisory committees, which can contribute to unnecessary delays for patients. In response to this problem, the legislation would restore the appropriate balance to conflicts of interest requirements by requiring the FDA to be subject to the same conflicts of interest requirements as the rest of the federal government.

“It is critical that we don’t allow regulatory burdens to get in the way of delivering lifesaving products to the patients who need them,” Klobuchar said. “This legislation will help ensure that we have processes that promote safe, pioneering technologies that help save lives and create good jobs” throughout America.

“In order to provide American patients access to the most cutting-edge medical therapies and advances, we need to fix what is broken at the FDA by restoring regulatory certainty and predictability,” Senator Burr said. “By streamlining and ensuring the least burdensome approach to FDA’s regulation of medical devices, we not only take a key step toward restoring America’s leadership in the research and development of life-saving products, but uphold our promise to patients in North Carolina and around our nation to continue innovating on their behalf.”

Bennet recognized the need to work “with the FDA to ensure that it modernizes its regulatory system to foster innovation and drive the economy.” “This bill would help provide our nation’s medical device developers and manufacturers with the regulatory clarity and predictability that would give our patients the greatest access to lifesaving products and boost our national economic competitiveness.”

Discussion

In a press release announcing this important legislation, the Senators pointed out how FDA’s regulation over the past few years “has become increasingly longer and more difficult, delaying, and in some cases preventing, new and innovative devices from reaching the market.” They cited recent studies, which showed that the average time to approve a 510(k) application has increased 43% from the 2003-2007 period to 2010, and the average time to approve a premarket approval (PMA) application has increased 75%. A recent survey of venture capitalist life sciences investors showed that almost 40% of investors are more likely to shift their operations and investments overseas because of FDA’s regulatory challenges.

The senators’ legislation would help streamline the FDA’s regulation of medical devices by clarifying FDA’s current least burdensome requirements. These provisions will ensure that when making regulatory decisions on medical devices, FDA focuses only on the relevant information during the decision-making process, considers appropriate alternatives to reduce the time, effort, and cost of reaching regulatory decisions, and uses all reasonable mechanisms to reduce review times when making these decisions.

Klobuchar is the chair of the Senate Commerce Subcommittee on Competitiveness, Innovation, and Export Promotion, and has been a leader in the effort to cut red tape that threatens innovation in the medical device industry. After a December 2010 report surveyed over 200 medical technology companies and found that confusing and contradictory regulations are stifling innovation, Klobuchar pushed FDA to reform its slow and inconsistent 510(k) approval process for medical devices to maintain safety, protect patients, and encourage innovation. Klobuchar also founded the bipartisan Senate Medical Technology Caucus to increase awareness about issues facing the industry.

Bennet, a member of the Senate Committee on Health, Education, Labor and Pensions, sent a letter to FDA Commissioner Margaret Hamburg in August pushing for reformed FDA regulations that foster innovation and competitiveness and position the FDA to serve as a driver of the global economy. Following the letter, Hamburg joined Bennet to hear about innovation and advances in the bioscience industry in Colorado while touring the Colorado Science and Technology Park at Anschutz Medical Campus.

Conclusion

Ultimately, this legislation will be an important step towards changing the conflict of interest rules at FDA to ensure a proper balance that will spur innovation and scientific progress and bring to patients the best and latest treatments, while also giving more certainty to industry and investors, thus creating more revenue for States as well as jobs. Moreover, the legislation will be critical for medical device companies, investors, employees, and patients depending on such products.

With a more certain and predictable regulatory process, America can begin to recruit more medical device companies and manufacturers, which will lead to more jobs, more tax revenue, and more importantly, better and safer devices that will improve the health and well being of millions of Americans.